Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00106704
Recruitment Status : Completed
First Posted : March 30, 2005
Results First Posted : December 17, 2010
Last Update Posted : July 1, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

March 29, 2005
March 30, 2005
November 19, 2010
December 17, 2010
July 1, 2015
March 2005
June 2006   (Final data collection date for primary outcome measure)
Change From Baseline in A1C at Week 24 [ Time Frame: Baseline and 24 Weeks ]
Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
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Complete list of historical versions of study NCT00106704 on Archive Site
Change From Baseline in FPG at Week 24 [ Time Frame: Baseline and 24 Weeks ]
The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.
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Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)
A Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Glimepiride Alone or in Combination With Metformin
The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with Type 2 diabetes mellitus.
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Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Comparator: Sitagliptin
    sitagliptin 10 mg tablet, once daily for 54 weeks
  • Drug: Comparator: Placebo
    Placebo oral tablet once daily for 24 weeks
  • Drug: Comparator: Pioglitazone
    Pioglitazone 30 mg tablet once daily for 30 weeks
  • Experimental: Sitagliptin
    Sitagliptin 10 mg tablet daily for 54 weeks
    Intervention: Drug: Comparator: Sitagliptin
  • Placebo Comparator: Placebo/ Pioglitazone
    Placebo tablet daily for 24 weeks followed by Pioglitazone tablet daily for 30 weeks
    • Drug: Comparator: Placebo
    • Drug: Comparator: Pioglitazone
Hermansen K, Kipnes M, Luo E, Fanurik D, Khatami H, Stein P; Sitagliptin Study 035 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab. 2007 Sep;9(5):733-45. Epub 2007 Jun 26.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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January 2007
June 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with Type 2 Diabetes Mellitus with inadequate glycemic control

Exclusion Criteria:

  • Patients with Type 1 Diabetes Mellitus
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Australia,   Austria,   Canada,   Costa Rica,   Czech Republic,   Denmark,   France,   Guatemala,   Hong Kong,   Israel,   Italy,   Korea, Republic of,   Mexico,   Norway,   Peru,   Philippines,   Portugal,   Spain,   Sweden,   Taiwan,   Thailand,   United States
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP